secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2024-10-25T23:59:59+00:00
Accession:  0001193125-24-243413
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA reports 33% ORR in Phase 1 IDE397 in MTAP-deletion urothelial cancer and NSCLC
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- Overall response rate 33% (1 CR, 8 PR) in 27 evaluable patients; all 9 responses confirmed.
- Confirmed ORR by tumor: 40% (4/10) urothelial, 38% (3/8) squamous NSCLC, 22% (2/9) adenocarcinoma NSCLC.
- Disease control rate 93%; median treatment duration >6.2 months; 15 of 27 patients still on treatment.
- ctDNA molecular response rate 81% (≥50% reduction) and 33% (≥90% reduction) in 21 reportable patients.
- Favorable safety: 18% Grade 3+ drug-related AEs; no drug-related SAEs or discontinuations; IDE397 + Trodelvy combo to start Q4 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524243413/0001193125-24-243413-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524243413/d898951d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-243413

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer